Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-06-05FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- 2024-06-05FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- 2024-06-05FDA-DeviceMirion Technologies (Capintec), Inc.Class IICaptus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
- 2024-06-05FDA-DeviceMirion Technologies (Capintec), Inc.Class IICaptus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
- 2024-06-05FDA-DeviceMirion Technologies (Capintec), Inc.Class IICaptus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
- 2024-06-05FDA-DeviceCovidien, LPClass IITri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
- 2024-06-05FDA-DeviceBoston Scientific Neuromodulation CorporationClass IIVercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
- 2024-06-05FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IMedline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID. Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits: (1) Medline Intubation Kit - D
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
- 2024-05-29FDA-DeviceJiangsu Shenli Medical Production Co., Ltd.Class IIBrand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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